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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM
Classification Namestent, carotid
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP050025
Supplement NumberS006
Date Received07/26/2007
Decision Date08/24/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a 100% inspection test to be implemented in receiving inspection and a 100% in-process visual verification to ensure that connector blocks properly transmit uv light.
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